Summary

A yellow caution flag was urgently waved last week in front of researchers racing to develop complex molecular tests for use in medical care. An Institute of Medicine (IOM) review of flawed research at Duke University found many missteps in how scientists and physicians there developed genetic signatures to guide cancer treatment. And the problems aren't limited to Duke: The IOM report concluded that so-called omics tests—diagnostic and prognostic tools based on patterns of nucleic acids, proteins, or other molecules in tissues such as blood—are highly prone to errors; it recommended that any future tests be rigorously validated before their use in clinical trials. The report also calls on institutions, funders, and journals to take steps to avoid the research management problems it examined at Duke.